BS ISO 18668-2:2017 - Comprehensive Guide for Health Care Technology

The BS ISO 18668-2:2017 standard represents a crucial framework within the realm of health care technology, focusing specifically on the evaluation of medical devices intended for use in hospitals and healthcare settings. This document provides detailed guidelines and methodologies aimed at ensuring the safety, efficacy, and performance of medical devices. As technology continues to advance at a rapid pace, compliance with such standards has never been more vital for manufacturers and healthcare professionals alike.

This standard is part of a series developed under international consensus, and it aligns with the overarching ISO 18668 framework. By employing the methodologies described, organizations can systematically assess risks, ensure quality control, and optimize overall device functionality while adhering to prescribed regulatory requirements.

Key Features of BS ISO 18668-2:2017

• Comprehensive Evaluation Criteria: Outlined assessment criteria for safety, effectiveness, and quality assurance allowing for uniform evaluation of various devices.
• Guideline on Medical Device Classification: Provides clarity on how devices are classified based on risk factors, performance characteristics, and intended use.
• Risk Management Practices: Emphasizes the importance of risk management throughout the device lifecycle, from development through post-market surveillance.

Benefits of Adopting BS ISO 18668-2:2017

Organizations that adopt this standard can expect enhanced product quality, reduced risk of adverse events, and improved customer satisfaction through greater reliability and usability of medical devices. Furthermore, compliance not only facilitates smoother regulatory approvals but also fosters a culture of safety within healthcare environments.

The investment of £330.00 for this standard reflects its value in enhancing operational efficiency and ensuring compliance with global best practices. Available in PDF and hardcopy formats, this document serves as an essential resource for quality managers, regulatory affairs professionals, and engineers within the medical device sector.

Conclusion

In an increasingly complex healthcare landscape, adhering to standards such as BS ISO 18668-2:2017 can make a substantial difference in device quality and patient outcomes. To secure the future of healthcare technology, ensure your organization is aligned with this critical standard.